Track Risk Management Plans

Learn how to track your global and local risk management plans (RMPs) and their related documents.

About Risk Management Plans

With Vault SafetyDocs, you can track the authoring, approval, and distribution of global and local risk management plans (RMPs) and additional risk minimization measures (aRMMs), as well as categorize and track identified risks with measures to be taken globally and by market.

RMP Creation Outline

The sections in this article describe how to create Core and Local Risk Management Plans, Risk Measures, and Implementation Strategies as outlined below:

Risk Management Plans

To create risk management plans:

  1. Create a Core Risk Management Plan: How to create a Core Risk Management Plan (Core RMP) for a Product, including an initial Core Risk Management Plan Version (Core RMP Version) that contains the related Risk and Risk Measure records for that version.
  2. Create Local RMPs from a Core RMP: How to create the Local RMPs from a Core RMP Version.
  3. Create a New Core RMP Version: How to create a new version of a Core RMP when a Core RMP must be updated with new information.
  4. Make a Core RMP Version Obsolete: When required, how to make a Core RMP Version obsolete.

Risk Measures

To create risk measures for risk management plans:

  1. Create Core Risk Measures: How to create Risk Measure records for each identified Risk in a Core RMP Version.
  2. Create Local Risk Measures: How to create additional Local Risk Measure records for an identified Risk in a Local RMP Version.

Implementation Strategies

To create implementation strategies:

  1. Create a Core Implementation Strategy: How to create an RMP Core Implementation Strategy record for a Core RMP, including related documents and Risk Measure records.
  2. Create Local Implementation Strategies from a Core Implementation Strategy: How to create the RMP Local Implementation Strategy records from a RMP Core Implementation Strategy.
  3. Create a New Core Implementation Strategy Version: How to create a new version of a core implementation strategy when a core implementation strategy must be updated with new information.

Prerequisite

Your Admin must configure your Vault for Risk Management.

Create a Core Risk Management Plan

Complete the following steps to create a Core Risk Management Plan:

  1. Navigate to Risk Management > Core RMPs.
  2. Select Create.
  3. Complete the fields on the Create Core Risk Management Plan page.
  4. Select Save.
Field Description
Name Enter a name for the Core Risk Management Plan.
Product Family Select the Product Family of the Product that this RMP is for.
Product Select the Product for this RMP.
Substance (Optional) Select the active Substance for this RMP.
Product Launch Date Enter the date of the first global registration for this Product.
Effective Version Enter the version that is the current effective global RMP for this Product.

Result

Once you save the Core RMP, the following sections appear:

Core RMP Versions

In the Core RMP Versions section, create a record for the initial version of the Core RMP.

Select Create and complete the following fields:

Field Description
Name Enter a name for the Core Risk Management Plan Version.
Version Enter the version number for this RMP Version.
Based On For the initial version, leave this field blank.
Data Lock Point Enter the date for which all information in this Core RMP Version is valid.
Effective Date (Optional) Enter the final approval date for this Core RMP Version.

You can enter additional information about the Core RMP Version in the following text fields:

  • Rational for Latest Version
  • Summary of Significant Changes

Result

Once you save the Core RMP Version, the following sections appear:

RMP Risks

In the RMP Risks section, create a record for each of the identified risks associated with the Product.

Select Create and complete the following fields:

Field Description
Name Enter a name for the RMP Risk.
Risk Category Select which category the RMP Risk belongs in:
  • Identified Risk
  • Potential Risk
  • Missing Information
Risk Sub-Category Select the sub-category the RMP Risk belongs in:
  • Potential harm from overdose
  • Potential for risks resulting from medication errors
  • Potential for transmission of infectious agents
  • Potential for off-label use
  • Risk common to other members of the pharmacological class
  • Potential pharmacokinetic and pharmacodynamic interactions
  • Pregnant and lactating women
  • Effect on fertility
  • Risks associated with disposal
  • Risks related to the administration procedure
  • Paediatric safety issues
MedDRA

Enter a search term for any level of the MedDRA hierarchy and then select Auto-code or the Advanced Search (Binoculars icon) icon to search in the MedDRA Browser.

Alternatively, enter a MedDRA Query as described below.
MedDRA Query If you did not select a MedDRA term, select the Advanced Search icon to find a MedDRA Query.

You can enter additional information about the Risk in the following information in the following text fields:

  • Risk Description
  • Risk Seriousness
  • Risk Frequency
  • Risk-Benefit Impact

Use the breadcrumb trail to navigate back to the Core RMP Version record.

Documents

In the Documents section, add any related documents for the Core RMP Version.

When uploading RMP documents, use the Risk Management > Risk Management Plan > Core RMP document type.

Upload RMP documents using the same process as for other document types. For more information, see Creating Documents.

Use the breadcrumb trail to navigate back to the Core RMP Version record.

Local RMP Versions

This section lists any Local RMP Versions for this Core RMP Version, whether they were created manually, or using the Create Local RMPs action.

Once all the information for the Core RMP Version is complete, use the breadcrumb trail to navigate back to the parent Core RMP record.

Local RMPs

This section lists the Local RMPs created from the Core RMP.

This list is blank initially. Once you have created a Core RMP and a Core RMP Version, create Local RMPs from a Core RMP.

Documents

In the Documents section of the Core RMP record, add any related documents for the Core RMP.

When uploading RMP documents, use the Risk Management > Risk Management Plan > Core RMP document type.

Upload RMP documents using the same process as for other document types. For more information, see Creating Documents.

Create Local RMPs from a Core RMP

Vault can create Local RMPs from a Core RMP, including all its related documents, for each region that requires risk management plans.

Create Local RMPs from a Core RMP Version

Complete the following steps to create Local RMP records from a Core RMP Version:

  1. Navigate to Risk Management > Core RMPs > [Core RMP].
  2. Expand the Core RMP Versions section and select the Core RMP Version record you want to create Local RMPs for.
  3. Select All Actions > Create Local RMPs.

Result

Vault sends a notification after the Create Local Implementations action finishes running and creates the following records:

  • Local RMP (if missing)
  • Local RMP Version

Local RMP Records

Vault creates a Local RMP record for each Country in which the following criteria apply:

  • The Product Family reference on the Core RMP is registered on a Product Registration
  • The country’s RMP Required field has a value of RMP Required
  • A Local RMP record does not yet exist

Vault populates any new Local RMP records as follows:

Field Value
Name The name of the Core Risk Management Plan plus the name of the Market.
Core Risk Management Plan The Core RMP record referenced on the Core RMP Version record.
Market The Country of the Local RMP record.
Substance Vault maps this value from the Core RMP record.
Product Family Vault maps this value from the Core RMP record.
Product Vault maps this value from the Core RMP record.
Market Launch Date The current date.
Effective Version Vault leaves this field blank.

Local RMP Version Records

Vault creates a Local RMP Version record for each Local RMP record created above that is not in the Not Applicable state, and populates the record as follows:

Field Value
Name The name of the Core Risk Management Plan plus the name of the Market plus the Version.
Local Risk Management Plan The Local RMP for the specific country.
Core Risk Management Plan Version The record from which the action was started.
Version If there are any previous RMP versions for this market, Vault takes the highest value and adds one (1). Otherwise, Vault sets the version to 1.0.
Data Lock Point The current date.
Approval Date Vault leaves this field blank.
Effective Date Vault leaves this field blank.
Rationale for Latest Version Copies the value from the Core RMP Version on which the action was started.
Summary of Significant Changes Copies the value from the Core RMP Version on which the action was started.

Create Local RMP Data from the Core RMP

Complete the following steps to create Local RMP data from a Core RMP:

  1. Navigate to Risk Management > Local RMPs > [Local RMP].
  2. Expand the Local RMP Versions section and select the Local RMP Version you want to create Local RMP data for.
  3. Select All Actions > Create Local RMP Data from Core.

Result

Vault performs the following actions to create Local RMP record data:

Create Local RMP Risk Records

Vault creates a Local RMP Risk record for each RMP Risk Record on the related Core RMP Version, copying their field values.

Vault copies from the current steady-state Local RMP Version any Local RMP Risk records whose Core Risk field is blank.

Create New Working Documents for Local RMP Risk Records

Vault creates a new Working Document for the Local RMP Version, as follows:

  • Copies the latest version of any Working Documents related to the Core RMP Version (classification: Risk Management-Risk Management Plan-Core RMP AND “Master or Working” = Working”
  • If no document exists, Vault creates a new document with the following settings:
Field Value
Classification Vault classifies the document as Risk Management > Risk Management Plan > Local RMP.
Name Vault sets the name as (Local RMP Version.Name)-v(version number)-Working.
Market The Country on the Local RMP record.
Core Risk Management Plan Vault maps this value from the Core document.
Core RMP Version Vault maps this value from the Core document.
Master or Working Vault sets this field to Working.
Local Risk Management Plan The Local RMP of the initiating Local RMP Version record.
Local RMP Version The initiating Local RMP Version record.

Create a New Core RMP Version

Complete the following steps to create a new version of a Core RMP:

  1. Navigate to Risk Management > Core RMPs > [Core RMP].
  2. Expand the Core RMP Versions section and select the Core RMP Version record of which you want to create a new version.
  3. Select All Actions > Copy to New Version.

Result

Vault sends a notification after the Copy to New Version action finishes running and copies the following records:

Core RMP Version Record

Vault makes a copy of the Core RMP Version record, setting the fields as follows:

Field Value
Name The name of the Core RMP appended with -v and the Version Number.
If this field exceeds the character limit, Vault truncates it.
Core Risk Management Plan Same as the Core RMP Version record that was copied.
Data Lock Point The current date.
Version Previous version number plus one (1).
Based On The Core RMP Version record that was copied.
Effective Date Vault leaves this field blank.
Summary of Significant Changes Vault leaves this field blank.
Rationale for Latest Version Vault leaves this field blank.

Risk Records

Vault makes a copy of all the Core RMP Version’s Risk records and copies all field values.

Documents

Vault makes a copy of any documents whose fields match the following criteria:

  • Type: Risk Management
  • Subtype: Risk Management Plan
  • Classification: Core RMP
  • Core RMP Version: Same as the Core RMP Version record being copied
  • Master or Working: Master

If multiple documents have the same Core RMP Version, Vault selects the document with the latest document Version field value.

Make a Core RMP Version Obsolete

Complete the following steps to make a Core RMP Version obsolete:

  1. Navigate to Risk Management > Core RMPs > [Core RMP].
  2. Expand the Core RMP Versions section and select the Core RMP Version record you want to make obsolete.
  3. Select All Actions > Make Obsolete.

Create Core Risk Measures

Complete the following steps to create the risk measures for a Core Risk Management Plan Version:

  1. Navigate to Risk Management > Core RMPs > [Core RMP].
  2. In the Core RMP Versions section, select the required Core RMP Version record. This is usually the latest version.
  3. In the Identified Risks section, select the required RMP Risk record.
  4. In the Risk Measures section, create a record for each risk measure associated with the selected RMP Risk record:
    1. Select Create and in the Create RMP Risk Measure window, select Core Risk Measure.
    2. Complete the Core Risk Measure fields.
    3. Select Save.
    4. In the Documents section of the Core Risk Measure record, add any related documents for the Risk Measure.
      When uploading risk measure documents, use the Risk Management > Risk Measure > Risk Measure Tool document type. Upload risk measure documents using the same process as for other document types. For more information, see Creating Documents.
  5. Repeat steps 3 and 4 to create risk measures for each additional RMP Risk record.

Core Risk Measure Fields

Field Description
Name Vault populates this field automatically.
Minimized Risk Select the RMP Risk for the Core Risk Measure.
Indication Select the MedDRA term for the indication.
Routine/Additional Select whether the Core Risk Measure is Routine or Additional.
Measure Category Select the type of risk minimization measure.

The options available depend on the selection you made for the Routine/Additional field.

The following options are available for routine Core Risk Measures:

  • Summary of Product Characteristics
  • Labeling
  • Package Leaflet
  • Pack Size
  • Legal Status of Product

The following options are available for additional Core Risk Measures:

  • Educational Materials
  • Direct Healthcare Professional Communications
  • Pregnancy Prevention Programmes
  • Controlled Access Programs
Measure Sub-Category If you defined this Core Risk Measure as Additional, select the appropriate sub-category.

If you selected the Educational Materials category, the following options are available:

  • Guides for patients or healthcare professionals for risk minimization
  • Healthcare professional checklists for risk minimisation
  • Risk awareness forms
  • Demonstration kits
  • Patient diaries for risk minimisation
  • Patient cards

If you selected the Controlled Access Programmes category, the following options are available:

  • Controlled prescription and supply system
  • Center accreditation systems
  • Forms for patient information exchange between prescriber and dispenser
  • Dispensing forms

Core Implementation Strategy Select the Core Implementation Strategy for the Core Risk Measure from the drop-down or select the Advanced Search (Binoculars icon) icon to use filters and refine your search.

If the drop-down is blank, you must create a Core Implementation Strategy first.

Version Enter the applicable version number for the Core Risk Measure.
Based On If applicable, select the Risk Measure record on which this Core Risk Measure record is based.
Planned Start Date Enter the Risk Measure's expected start date.

Use the calendar to select the date or enter the date manually.

Actual Start Date Enter the actual date the Risk Measure came into force.

Use the calendar to select the date or enter the date manually.

Actual End Date Enter the actual date the Risk Measure ended.

Use the calendar to select the date or enter the date manually.

Create Local Risk Measures

When the Create Local RMPs action creates Local Risk Management Plan Version records, these records inherit a copy of the Risk Measure records from their parent Core Risk Management Plan Version.

If required, complete the following steps to create additional risk measures for a Local Risk Management Plan Version:

  1. Navigate to Risk Management > Local RMPs > [Local RMP].
  2. In the Local RMP Versions section, select the required Local RMP Version record. This is usually the latest version.
  3. In the Local Risks section, select the required Local RMP Risk record.
  4. In the Risk Measures section, create a record for each risk measure associated with the selected Local RMP Risk record:
    1. Select Create and in the Create RMP Risk Measure window, select Local Risk Measure.
    2. Complete the Local Risk Measure fields.
    3. Select Save.
    4. In the Documents section of the Local Risk Measure record, add any related documents for the Risk Measure.
      When uploading risk measure documents, use the Risk Management > Risk Measure > Risk Measure Tool document type. Upload risk measure documents using the same process as for other document types. For more information, see Creating Documents.
    5. In the Risk Measure Tracking section, select Create and complete the RMP Risk Measure Tracking Fields.
    6. Select Save.
    7. Use the breadcrumb trail to navigate back to the Local Risk Measure record.
  5. Repeat steps 3 and 4 to create risk measures for each additional RMP Risk record.

Local Risk Measure Fields

Field Description
Name Vault populates this field automatically.
Minimized Risk To populate this field, you must first specify an RMP and RMP Version in the Implementation section below. Select the RMP Risk for the Local Risk Measure from the drop-down or select the Advanced Search (Binoculars icon) icon to use filters and refine your search.
Minimized Local Risk If Vault does not populate this field automatically, select the specific risk that this measure will help to minimize in the local market from the drop-down or select the Advanced Search (Binoculars icon) icon to use filters and refine your search.
Indication Select the MedDRA term for the indication.
Routine/Additional Select whether the Local Risk Measure is Routine or Additional.
Measure Category Select the type of risk minimization measure.

The options available depend on the selection you made for the Routine/Additional field.

The following options are available for routine Local Risk Measures:

  • Summary of Product Characteristics
  • Labeling
  • Package Leaflet
  • Pack Size
  • Legal Status of Product

The following options are available for additional Local Risk Measures:

  • Educational Materials
  • Direct Healthcare Professional Communications
  • Pregnancy Prevention Programmes
  • Controlled Access Programs
Measure Sub-Category If you defined this Local Risk Measure as Additional, select the appropriate sub-category.

If you selected the Educational Materials category, the following options are available:

  • Guides for patients or healthcare professionals for risk minimization
  • Healthcare professional checklists for risk minimisation
  • Risk awareness forms
  • Demonstration kits
  • Patient diaries for risk minimisation
  • Patient cards

If you selected the Controlled Access Programmes category, the following options are available:

  • Controlled prescription and supply system
  • Center accreditation systems
  • Forms for patient information exchange between prescriber and dispenser
  • Dispensing forms
Core Risk Measure Select the core Risk Measure on which this local Risk Measure is based from the drop-down or select the Advanced Search (Binoculars icon) icon to use filters and refine your search.
Market Select the Country to which this local Risk Measure applies from the drop-down or select the Advanced Search (Binoculars icon) icon to use filters and refine your search.
Local Disposition Select how the local Risk Measure will be used in the applicable region:
  • Core As Is: Use the Local Risk Measure in the same way as the Core Risk Measure.
  • Core Modified: Use the Local Risk Measure in the same way as the Core Risk Measure, but with some modifications.
  • Country Specific: Use the Local Risk Measure in a way that is specific to the applicable Country.
  • Not Applicable: The Local Risk Measure is not applicable to this region.
Version Enter the applicable version number for the Local Risk Measure.
Based On If applicable, select the Risk Measure record on which this Local Risk Measure record is based from the drop-down or select the Advanced Search (Binoculars icon) icon to use filters and refine your search.
RMP Select the RMP for the Core Risk Measure from the drop-down or select the Advanced Search (Binoculars icon) icon to use filters and refine your search.
RMP Version Select the RMP Version for the Core Risk Measure from the drop-down or select the Advanced Search (Binoculars icon) icon to use filters and refine your search.
Local RMP Vault populates this field automatically.
Local RMP Version Vault populates this field automatically.
Core Implementation Strategy Select the Core Implementation Strategy for the Core Risk Measure from the drop-down or select the Advanced Search (Binoculars icon) icon to use filters and refine your search.

If the drop-down is blank, you must create a Core Implementation Strategy first.

Local Implementation Strategy Select the Local Implementation Strategy that covers the development of this minimization tool from the drop-down or select the Advanced Search (Binoculars icon) icon to use filters and refine your search.
HA Submission Date Enter the date the Risk Measure was submitted to the health authority for endorsement.

Use the calendar to select the date or enter the date manually.

HA Endorsement Date Enter the date the Risk Measure was endorsed by the health authority for use.

Use the calendar to select the date or enter the date manually.

Planned Start Date Enter the Risk Measure's expected start date.

Use the calendar to select the date or enter the date manually.

Actual Start Date Enter the actual date the Risk Measure started.

Use the calendar to select the date or enter the date manually.

Actual End Date Enter the actual date the Risk Measure ended.

Use the calendar to select the date or enter the date manually.

RMP Risk Measure Tracking Fields

Field Description
Target Date

Enter the target date for distribution of the Risk Measure.

Use the calendar to select the date or enter the date manually.

Target Completion Date

Enter the expected tracking period end date for the Risk Measure.

Use the calendar to select the date or enter the date manually.

Target Value

Enter the target outcome of the Risk Measure.

Outcome Verdict

Select the evaluation of the actual outcome of the Risk Measure:

  • Target Met
  • Target Missed
  • Target Cancelled
Channel

Enter the distribution channel for the Risk Measure.

Actual Date

Enter the date that the outcome of the Risk Measure was recorded.

Use the calendar to select the date or enter the date manually.

Actual Completion Date

Enter the date that the tracking period of the Risk Measure ended.

Use the calendar to select the date or enter the date manually.

Actual Value

Enter the actual outcome of the Risk Measure.

Create a Core Implementation Strategy

Complete the following steps to create a Core Implementation Strategy:

  1. Navigate to Risk Management > Core Implementation Strategies.
  2. Select Create.
  3. Complete the fields on the Create RMP Core Implementation Strategy page.
  4. Select Save.
Field Description
Name Enter a name for the Core Implementation Strategy.
Product Family Select the Product Family of the Product that this implementation strategy is for.
Based On Select the previous implementation strategy on which this Core Implementation Strategy is based.
Core Implementation Plan From your document library, select the document that describes the strategy for Risk Measure implementation. The document must be classified as Risk Management > Risk Measure > Implementation Plan.

Upload risk measure implementation plan documents using the same process as for other document types. For more information, see Creating Documents.

Version Select the version of the Core Implementation Plan document.
Core RMP Select the Core RMP for the implementation strategy.

Result

The following sections appear:

Documents

In the Documents section, add any related documents for the Core Implementation Strategy.

Upload implementation strategy documents using the same process as for other document types. For more information, see Creating Documents.

Risk Measures

If you selected a Core RMP for this Core Implementation Strategy, generated Risk Measure records appear in the Risk Measures section.

To create additional Risk Measures for this Core Implementation Strategy, complete the following steps:

  1. Select Create.
  2. Complete the fields shown in Core Risk Measure Fields.
  3. Select Save.

Create Local Implementation Strategies from a Core Implementation Strategy

Vault can create implementation strategies from a Core Implementation Strategy, including all its related documents, for each region that requires risk implementation strategies.

Create Local Implementation Strategies

Complete the following steps to create Local Implementation Strategy records from a Core Implementation Strategy:

  1. Navigate to Risk Management > Core Implementation Strategies > [Core Implementation Strategy].
  2. Select All Actions > Create Local Implementations.

Result

Vault sends a notification after the Create Local Implementations action finishes running. Vault performs the following actions to create Local Implementation Strategy records:

Copy Based On Local Implementation Strategy Records

Vault copies all Local Implementation Strategy records associated with the Core Implementation Strategy record in the Based On field of the initiating Core Implementation Strategy. Vault copies all field values with the following exceptions:

Field Value
Name The name of the Core Implementation Strategy plus the Market Name.
Product Family The Product Family of the initiating Core Implementation Strategy.
Core Implementation Strategy The initiating Core Implementation Strategy.
Based On The copied Local Implementation Strategy.
Pre Launch Date Vault leaves this field blank.
Actual Launch Date Vault leaves this field blank.

Create Draft Documents

Vault creates a draft of the document in the Local Implementation Plan field on the initiating Core Implementation Strategy record and links the new version of the document to the new Local Implementation Strategy record.

Create New Local Implementation Strategy Records

Vault creates a Local Implementation Strategy record for each Country in which the Product reference on the Core Implementation Strategy is registered and the country’s RMP Required field has a value of RMP Required and a Local Implementation Strategy record does not yet exist.

Vault populates any new Local Implementation Strategy records as follows:

Field Value
Name The name of the Core Implementation Strategy plus the Market Name.
Market The Country of this Local Implementation Strategy.
Product Family The Product Family of the Core Implementation Strategy.
Core Implementation Strategy The initiating Core Implementation Strategy.
Based On Vault leaves this field blank.
Version Vault leaves this field blank.
Pre Launch Date Vault leaves this field blank.
Actual Launch Date Vault leaves this field blank.

Create New Local Risk Measure Records

Vault creates a Local Risk Measure record for each Core Risk Measure on the Core Implementation Strategy.

Create Local Risk Measure Tool Documents

Vault creates a copy of any Risk Measure Tool documents with a Master or Working field value of Working on each Core Risk Measure on the Core Implementation Strategy. Vault then associates each document copy with the corresponding newly-created Local Risk Measure record.

Create a New Core Implementation Strategy Version

To create a new version of a Core RMP, navigate to Risk Management > Core Implementation Strategies > [Core Implementation Strategy] and select All Actions > Copy to New Version.

Result

Vault sends a notification after the Copy to New Version action finishes running. When creating a new Core Implementation Strategy, Vault copies the following records:

Core Implementation Strategy Record

Vault creates a copy of the Core Implementation Strategy record and sets the fields as follows:

Field Value
Name The same as the copied Core Implementation Strategy record with an appended timestamp.
Core Implementation Strategy Same as the Core Implementation Strategy record that was copied.
Based On The copied Core Implementation Strategy record.
Version Vault adds one (1) major (+1.0) version number to the previous version.

All other fields contain the same value as the copied Core Implementation Strategy record.

Core Implementation Plan Documents

Vault creates a new draft of the document in the Core Implementation Plan field on the copied Core Implementation Strategy record, linking it to the new Core Implementation Strategy record.

Core Risk Measure Records

Vault creates a Core Risk Measure record for each Core Risk Measure on the initiating Core Implementation Strategy.

Core Risk Measure Tool Documents

Vault creates a copy of any Risk Measure Tool documents with a Master or Working field value of Master on each Core Risk Measure on the initiating Core Implementation Strategy. Vault then associates each document copy with the corresponding newly-created Core Risk Measure record.